Intrauterine device and injection mechanism

ABSTRACT

An improved intrauterine device that may be injected into the uterine cavity without puncturing the uterus and without subsequent expulsion therefrom. The improved injector mechanism used to introduce the device into the uterus is applied only in the cervical canal, towards but not beyond the internal os. Regardless of the conformation of the uterus the device automatically expands in the endometrial cavity.

[11] 3,811,435 ]*May 21, 1974 United States Patent Soichet Meckstroth Massouras INTRAUTERINE DEVICE AND INJECTION 3,507,274

MECHANISM 2,122,579 7/1938 Samuel Soichet,4 E. 95th St., New York, NY. 10028 [76] Inventor:

Notice: vThe portion of the term of this patent subsequent to Apr. 21, 1987, has been disclaimed.

Oct. 20, 1.971

[22] Filed:'

Sofie 21 Appl. No.: 190,769

Related U.S. Application'Data [63] Continuation-impart of Ser. No. 5,466, Jan. 26,

ABSTRACT No. 3,678,927, which I97( Pat. continuation-in-part of Ser. No. 713,825, March 18, 1969, Pat. No. 3,507,274.

An improved intrauterine device that may be injected into the uterine cavity without puncturing the uterus and without subsequent expulsion therefrom. The improved injector mechanism used to introduce the de- 128/127 128 vice into the uterus isapplied only in the cervical ca- /2 d nal, towards but not beyond the internal 0s. Regardless'of the conformation of the uterus the device automatically expands in the .endometrial cavity.

[52'] 'U.S. Cl. [51] Int. [58] Field of Search References Cited UNITED STATES PATENTS 11 Claims','5 Drawing Figures Robinson..r................,........

ill lilwlli l- PATENIEDHAY 2 2 1974' I N VENTOR. 514M051 JW/C/VET INTRAUTERINE DEVICE AND INJECTION MECHANISM CROSS REFERENCE TO RELATED APPLICATIONS The present invention is a continuation-in-part of application Ser. No. 5,466, filed Jan. 26, 1970, now US. Pat. No. 3,678,927 in the name of Samuel Soichet and entitled INTRAUTERINE DEVICE AND INJECTOR THEREOF. This application discloses new and useful improvements in the device and injector mechanism disclosed in that prior application. Application Ser. No. 5,466 is in turn a continuation-in-part of application Ser. No. 713,825, filed Mar. 18, 1968, now U.S. Pat. 3,507,274, issued Apr. 21, 1970 and entitled INTRA- UTERINE DEVICE.

BACKGROUND OF THE INVENTION This invention relates to an improved Y-shaped intrauterine contraceptive device that keeps its rigid contour after insertion into the uterine cavity without puncturing the uterus and without subsequent expulsion therefrom. More particularly, this invention relates to an improved silicone covered Y-shaped stainless steel intrauterine contraceptive device capable of reaching from the cornua to the endocervical canal.

Prior intrauterine contraceptive devices, still in current use, have generated serious problems for the user concommitant with the purpose for which they have been designed. The most common and prevalent problems and difficulties with which the user must be concerned in utilizing prior art devices are expulsion of the device after insertion, perforation of the uterus walls on or after insertion and failure of the device to prevent a pregnancy.

The improved device of this invention is so sensitive to uterine contact that it may be used, without ill effects, in even nulligravidae or women who have never been pregnant. The device may, in addition, be easily and simply removed by grasping the tail portion of the device seated in the endocervical canal. The device of this invention also exhibits the desirable characteristics of contour retention after prolonged periods of use.

Other advantages and objects of this invention will become apparent from the more detailed description that follows:

SUMMARY OF THE INVENTION The improved intrauterine device of this invention includes two resilient outwardly springing inert medical grade metal wires, for instance nickel alloy wires, or preferably medical grade stainless steel wires, turned inwardly at their outer ends to form promontories or loops which provide an engagin'g structure. The resilient outwardly springing inert metal wires are joined at a common base portion and the base and wire arm elements substantially form a Y-shaped structure.

The Y-shaped wire structure may, preferably, be formed from a single strip of inert metal wire. The metal strip may be contoured and bent back upon itself at a common junction point and the divergent outwardly springing Y-members may be urged inwardly towards each other causing the base wire members to cross each other substantially at that junction point, as described in my copending application Ser. No. 5,466,

2 of which this application is acontinuation-in-part, and as shown in FIG. 3 thereof.

The springing Y-members and base wire members may thereafter be coated with or embodied in medical grade silicone rubber or tubing or other suitable thermoplastic material. For example, a preferred coating composition or tubing that may be used to encapsulate the Y-members and base member is Silastic a trademark of the Dow Corning Corp., Midland, Mich. used in connection with a composition comparable in physical character to milled, and compounded rubber prior to vulcanization, but containing organo-silicon polymers. The encapsulated base portion may be connected to an extension or tail member suitably formed of silicone rubber or other suitable materialsuch as Silastic. This extending member or tail member is loosely seated within the endocervical' canal and serves to facilitate removal of the device in addition to providing a guide means for ascertaining whether or not the device is properly in' place.

In this particularly improved form of the device, a web or bridging member extends between the resilient Y-member and joins the extending Y-members at a vertex point defining the incipient base portion of the device. The bridging member or web member joins each Y-member, one to the other, at a substantially intermediate portion of each extending Y-member and continuously descends to the vertex between Y-members.

The descending continuous web joining the Y- members increases the utility of the device and enhances its effectiveness. Devices formed with this web portion cover a larger surface area within the uterine cavity and in the event of a pregnancy prevent nidation or seeding of the fertilized egg. The web portion also serves to retain the resilient posture of the 'Y-members within the uterine cavity by preventing each Y-member from submitting to an outwardly urging pressure which would deform the members from their contoured shape.

The promontories or loops which provide an engaging surface at the outer end of each Y-member are designed to receive and be embodied in a plastic bead, such as silicone rubber, polyethylene or polypropylene beads and preferably beads formed from Silastic" adhesive. The design of the bead is directly related to the success of the device. The beads must be designed to accomplish their function as deflectors or stimulate utera-tubal contractions during those periods of time when the. user becomes susceptible to pregnancy; yet the design must be such as to avoid chronic irritation of the uterine walls in proximity to the device. In the improved device of this invention, the beads have been reduced in size to minimize the possibility that intrauterine pressure and bleeding may occur; however, the device still performs satisfactorily and under certain circumstances performs better than the device disclosed in my prior application.

According to an improved bead design, the face of each bead is substantially flat and the sides of the beads that may be mated, one with the other, when the Y- shaped members are urged towards and in contact with each other, are flattened to facilitate introduction of the device into the injector. The outward extension of each bead from the mating surface of each Y-member may be curved outwardly of the mating surface to provide an ovular end portion seated in the mouth of the injector and which may be readily inserted within the entrance of the uterine cavity. v

The injector includes an elongated tubular member with a collar adjacent the inlet or injector end of the tubular member. The collar limits the extent to which the tubular member may be inserted through the cervix of the uterine cavity. The collar extends outwardly from the elongated tubular member and around the entire perimeter of the tubular member. The tubular member is of sufficient dimension or diameter to receive the extension or tail member of the device as well as the upwardly extending Y-members when pressed together.

When the device is fully inserted within the elongated tubular member the beads engaging the loops or promontories formed in the resilient inert metal backbone of the device are seated within the injector mouth of the elongated tubular member and form a smooth, conicallike 'member for insertion through the cervix of the uterine cavity.. a

The injector may have a collar at the lower end of the elongated tubular member which facilitates manipulation of the injector by the second and third fingers during application by a user. Sliding'within the outer elongated tubular member is a hollow pusher or piston member which telescopes into the elongated tubular member to force the conical-like beaded members through the cervix of the uterine cavity.

It is a particular feature of this improved injector mechanism that the hollow piston member receives the extension or tail member of the device and has an annular lip portion which accommodates or seats the base portion of the device to which the tail member is joined within the elongated tubular member. It is another improved feature of the hollow piston member that it contains slotted sidewalls which extend downwardly from the annular seat portion of the piston member downwardly toward the pusher or insert member or knob affixed to the hollow piston member. As the hollow piston member telescopes upwardly through the elongated tubular member the abutting conical-like bead members may be thrust upwardly through the cervix of the uterine cavity releasing the resilient Y-members of the device within the uterine cavity and as the insert or mouth portion of the injector mechanism is withdrawn the extension or tail member of the device remains within the endocervical canal and vagina. The slotted hollow piston member facilitates entry and insertion of the device by providing a smoother easier application of the device. The slots are formed in the hollow piston member to characteristically provide a leaf-spring effect which provides the proper telescoping resistance to insure the smooth application of the device.

BRIEF DESCRIPTION OF THE DRAWINGS Additional advantages of the present invention will become more apparent from the following drawings in which like reference characters denote corresponding parts' throughout the several, views:

FIG. 1 is a side elongated longitudinal sectional view of the injector mechanism. with the intrauterine device in position before injection;

FIG. 2 is a diagrammatic side elevational view showing the intrauterine device with the Y-members in position in the body organ after injection and prior to retraction of the injector mechanism;

FIG. 3 is a side elongated longitudinal sectional view of the hollow piston member of the injector mechanism with a cutaway portion along the slots in the member;

FIG. 4 is an enlarged side sectional view showing the intrauterine device fully extended in isolation; and

FIG. 5 is a cross section through FIG. 3 taken along the line 5-5 in FIG. 3.

DETAILED DESCRIPTION OF THE EMBODIMENTS Referring now to FIGS. I, 2 and 4, the device 10 is pressed into injection position within injector mechanism 12 for subsequent insertion into uterine cavity 14. Device 10 is formed with metal or plastic backbone 16 contoured substantially into a V-shape. The backbone is, in this embodiment, a single strip of resilient stainless steel. The apex of each outwardly springing arm of resilient metal backbone member 16 is contoured to form a promontory I8. Backbone member 16 is coated with silicone rubber, Silastic or other suitable thermoplastic material. A metallic component such as copper or other metals with contraceptive properties, in powder form, may be incorporating within the silicone rubber or SilasticT' coating to impart well-known and desirable characteristics to the coating. Resilient Y- members or coated arms 20 are contoured to form common coated base portion 22. Web or bridging member 24 extends between resilient coated arms 20 and joins contoured coated arm members 20 at a vertex point defining incipient bulbous base member 22. The lower end 24 of bulbous base member 22 is inwardly recessed to form integrally with extension or tail member 26.

Tail member 26 is not formed about any portion of Y the resilient metallic backbone I6. It is readily deformable and may be easily manipulated without applying pressure thereto. It is similarly formed of silicone rubber or Silastic and is compatible with the coating ma terial applied to resilient backbone l6. Promontories 18 formed at the apex of each outwardly springing arm of resilient metal backbone member 16 are embodied in thermoplastic beads 28 made, for instance, of silicone rubber, polyethylene, polypropylene and preferably Silastic. The bead surfaces which abut when resilient Y-members 20 are pressed into contact are substantially flat as shown at 30. The outer face of each bead curves outwardly and is substantially circular in appearance as shown at 32. The face of each bead 28 parallel to web 24 is substantially flat. According to the improved bead construction of this invention the beads have been reducedin size to minimize the possibility that uterine irritation 'and bleeding may occur. Typical dimension in the new small bead construction are 3 mm. (length) X 2 mm.

(width) X 2 mm. (thick). These dimensions may be compared with the ellipsoidally constructed beads disclosed in my U.S. Pat. No. 3,507,274 in which typical, respective, dimensions may be 6.5 mm. X 4 mm. X 3

like shape which may be readily and easily forced through the cervix of the uterine cavity.

Collar 36 extends outwardly from elongated tubular member 34 and around the entire perimeter of tubular member 34. Collar 38 similarly extends outwardly and around the entire perimeter of tubular member 34 at the lower end of tubular member 34 and facilitates manipulation of injector mechanism 12 by the second and third'fmgers during application by a user.

Hollow piston member 40 is of a smaller diameter than tubular member 34 and hollow piston member 40 slides within outer elongated tubular member 34 and telescopes into tubular member. 34. In a normal position, prior to injection of device through the cervix of the uterine cavity, hollow piston member 40 receives extension member 26 of device 10 through annular lip portion 42 as beads 28 remain seated within injector mouth 33 of elongated tubular member 34. The dimensions of annular lip portion 42 are such as to accommodate only extension member 26 of device 10 and the recessed porton of the lower base 24 is seated on annular lip 42 of hollow piston member 40.

After injection outlet 33 is properly placed in position at the cervix an upward pressure may be exerted on knob 44, connected to hollow piston member 40, and hollow pistonmember 40 may be telescoped upwardly within tubular member 34 and device 10 may be expelled through injector outlet 33 into the uterine cavity 14. Collar 36 restrains entry of tubular member 34 beyond the cervix of the uterine cavity.

As resilient Y-members are released through injector outlet 33 of elongated tubular member 34 they respond to the pressure release by leaving their abutting positions and reassuming their outward position. As shown in H0. 2, after Y-members and base member 22 are injected within uterine cavity 14, beads 28 rest upon uterine walls 46 in proximity to passageways 48 which lead to the Fallopian tubes (not shown) which in turn lead to the ovaries (not shown). After Y-members 20 and base member 22 of device 10 are expelled from within elongated tubular member 34 by the telescoping pressure exerted by hollow piston member 40, annular lip portion 42 of hollow piston member 40 is contiguous with injector mouth 33 of elongated tubular member 34.

Referring particularly to FIG. 2, as injector I2 is withdrawn from the cervix, extension member 26 remains seated within endocervical canal 50 to facilitate removal of device 10.

As particularly shown in FIGS. 3 and 5, hollow piston member 40 is slotted. Slot 52 extends downwardly along each side of piston member 40. Slot 52 begins at annular lip 42 and extends downwardly along each side of piston member 40 towards knob 44. The length and width of the slot is not critical, however, the slot should be deep enough on each side to provide a leaf spring action as hollow piston member 40 telescopes into and is withdrawn from elongated tubular member 34.

The reduced-bead design as described in conjunction with the improved intrauterine device of this invention facilitates insertion of this improved device particularlyin nulligravidae or women who have never been pregnant. Women who have never been pregnant usually appear more'sensitive to uterine irritation and concomitant bleeding. The improved bead design while still effective in women who have undergone one or more pregnancies may also be more effectively used in conjunction with nulligravidae.

Contraceptive results with all women whether or not they previously became pregnant may be attributed to the introduction of the fine web between the Y- member arms of the device. The web design enables the device to cover a larger surface area within the uterine cavity after insertion, prevents outward deformation of the Y-member arms and in the event that a pregnancy occurs would contribute in avoiding nidation or seeding of the fertilized egg.

While the present invention has been described in terms of specific embodiments, such as a stainless steel backbone with a silicone or Silastic covering it should be understood that various changes may be made in the preceding description without departing from the scope of the invention. In view of the above and other possible variations, therefore, it should be the lower most portion or vertex-between Y-arm members in the inert metal backbone, the inert metal backfurther having a flexible extension or tail member integrally connected with the bulbous coated base portion of the device, and a web member extending between the resilient, coated Y-arm members argl joining the divergentiyextending Y-arm members at a vertex point defining the incipient bulbous coated base portion of thedevice, the web member joining ch divergent coated Y-arm member, one to the other, at a substantially intermediate portion of each extending coated Y-arm member and continuously descending to the vertex between the coated Y-arm membersl. V

2. The improved intrauterine device of claim 1 in which the beads engaging and encapsulating the promontories formed at the apexes of the inert metal 'backbone in the device have the following dimensions:

3. An injector for a Y-shaped intrauterine device, said injector including a tubular barrel having an insert end, a collar positioned below the insertend to limit the insertion of the barrel, a finger grip portion at the lower end of the barrel, and a piston member capable of telescoping into the barrel and expelling a Y-shaped device from the insert end of the barrel, a hollow piston member adapted to receive the flexible extension or tail member of the Y-shaped device integrally connected with the bulbous coated base portion of the device, and

having an annular lip providing a circular seat for the circular recess formed in the bulbous. coated base portion of the Y-shaped device and having slotted side walls extending downwardly from the annular lip which characteristically provide a leaf spring effect as the hollow piston member telescopes into and out of the tubular barrel.

4. An intrauterine device comprising a resilient Y- shaped member, said resilient member having two arms gradually and continuously diverging upwardly and I outwardly from the intersection thereof adjacent the base portion of said resilient member; each of said arms being, at the uppermost portion thereof, curved outwardly, downwardly, and inwardly to form a bent-back portion in the form of a partial loop terminating short of contacting the body of the adjacent arm; said resilient member being totally encased in a plastic or rubber material; the encasement about each of said partial loops being in the form of a bead having a flat surface parallel to a plane passing through said resilient member, and a curved outside face along'said bent-back portion, said curved outside face adapted to contact the adjacent sidewall of the uterus when said intrauterine device is in position within the uterus, said contact being maintained during use by the resilient nature of saidresilient member; said arms being sufficiently resilible tail extending downwardly from said intersection and adapted to extend outwardly from the uterus through the cervix when said intrauterine device is in position within the uterus.

6. The intrauterine device of claim 4 further including a unitary web member extending between said encased arms, all of said web member being between said intersection and an imaginary line passing through said beads but covering less than the entire area between said intersection and said imaginary line.

7. The intrauterine device of claim 6 wherein said web member continuously descends, without opening or separation, from the upper edge thereof to said intersection.

8. The intrauterine device of claim 4 wherein said resilient member comprises stainless steel wire.

9; The intrauterine device of claim 4 wherein said 8. plastic or rubber material comprises medical grade silicone rubber.

10. An intrauterine device comprising a resilient Y- shaped member, said resilient member having two arms gradually and continuously diverging upwardly and outwardly from the intersection thereof adjacent the base portion of said resilient member; each of said arms being, at the uppermost portion thereof, curved outwardly, downwardly and inwardly to form a bent-back portion in the form of a partial loop terminating short of contacting the body of the adjacent arm; said resilient member being totally encased in a plastic or rubber material; the encasement about each of said partial loops being in the form of a bead having two flat surfaces parallel to each other and parallel to a plane passing through said resilient member, and a curved outside face along said bent-back portion, said curved outside face adapted to contact the adjacent sidewall of the uterus when said intrauterine device is in position with the uterus, said contact being maintained during use in the uterus by the resilient nature of said resilient member; said arms being sufficiently resilient so said arms can be urged together during positioning of said intrauterine device in an inserter for insertion of said intrauterine device into the uterus whereby adjacent flat surfaces on said beads will abut one another, and said curved outside faces will define a smooth leading-edge portion adapted to facilitate insertion of said intrauterine device intothe uterus; a unitary web member extending between said encased arms, all of said web member being between said intersection and a line passing through said beads, said web member continuously descending, without opening or separation, from the upper edge thereof to said intersection; and a flexible tail portion extending downwardly from said intersection and adapted to extend outwardly from the uterus through the cervix when said intrauterine device is inposition within the uterus.

11. The intrauterine device of claim 10 wherein said resilient member comprises medical grade stainless steel wire and said medical grade plastic or rubber material comprises silicone rubber.

* it A UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent No. 3 811 ,435 Dated May 21 1974 Inventor) S amue 1 Sci che t It is certified that error appears in the above-identified patent and that said Letters Patent are hereby corrected as shown below:

Column 6 line 51 Claim 2, after "dimensions" read:

-- 3 mm. (length) x 2 mm. (width) x 2 mm. (thick) Signed and sealed this 22nd day of April 1975.

(SEAL) Attest:

C. MARSHALL DANN RUTH C. MASON Commissioner of Patents Attesting Officer and Trademarks F OR PC 0 (10-6-9) uscoMM-oc 60376-P69 u.s eovzmmzu'r PRINTING OFFICE: 93 o 

1. A Y-shaped intrauterine device with an inert metal backbone, each resilient Y-arm member terminating in a promontory or loop at its apex and a base portion at the lower most portion or vertex between Y-arm members in the inert metal backbone, the inert metal backbone and said promontories being encapsulated in medical grade rubber or plastic material, said encapsulated promontories defining bead surfaces which may abut when said resilient coated Y-arm members are pressed into contact, the contoured outer face of each bead being substantially circular and the surface of each bead parallel to a plane passing through said resilient member being substantially flat; said device further having a flexible extension or tail member integrally connected with the bulbous coated base portion of the device, and a web member extending between the resilient, coated Y-arm members and joining the divergently extending Y-arm members at a vertex point defining the incipient bulbous coated base portion of the device, the web member joining each divergent coated Y-arm member, one to the other, at a substantially intermediate portion of each extending coated Y-arm member and continuously descendinG to the vertex between the coated Y-arm members.
 2. The improved intrauterine device of claim 1 in which the beads engaging and encapsulating the promontories formed at the apexes of the inert metal backbone in the device have the following dimensions:
 3. An injector for a Y-shaped intrauterine device, said injector including a tubular barrel having an insert end, a collar positioned below the insert end to limit the insertion of the barrel, a finger grip portion at the lower end of the barrel, and a piston member capable of telescoping into the barrel and expelling a Y-shaped device from the insert end of the barrel, a hollow piston member adapted to receive the flexible extension or tail member of the Y-shaped device integrally connected with the bulbous coated base portion of the device, and having an annular lip providing a circular seat for the circular recess formed in the bulbous coated base portion of the Y-shaped device and having slotted side walls extending downwardly from the annular lip which characteristically provide a leaf spring effect as the hollow piston member telescopes into and out of the tubular barrel.
 4. An intrauterine device comprising a resilient Y-shaped member, said resilient member having two arms gradually and continuously diverging upwardly and outwardly from the intersection thereof adjacent the base portion of said resilient member; each of said arms being, at the uppermost portion thereof, curved outwardly, downwardly, and inwardly to form a bent-back portion in the form of a partial loop terminating short of contacting the body of the adjacent arm; said resilient member being totally encased in a plastic or rubber material; the encasement about each of said partial loops being in the form of a bead having a flat surface parallel to a plane passing through said resilient member, and a curved outside face along said bent-back portion, said curved outside face adapted to contact the adjacent sidewall of the uterus when said intrauterine device is in position within the uterus, said contact being maintained during use by the resilient nature of said resilient member; said arms being sufficiently resilient so said arms can be urged together during positioning of said intrauterine device in an inserter for inserting said intrauterine device into the uterus whereby said flat surfaces on said beads will abut one another, and said curved outside faces will define a smooth leading-edge portion adapted to facilitate insertion of said intrauterine devices into the uterus.
 5. The intrauterine device of claim 4 including a flexible tail extending downwardly from said intersection and adapted to extend outwardly from the uterus through the cervix when said intrauterine device is in position within the uterus.
 6. The intrauterine device of claim 4 further including a unitary web member extending between said encased arms, all of said web member being between said intersection and an imaginary line passing through said beads but covering less than the entire area between said intersection and said imaginary line.
 7. The intrauterine device of claim 6 wherein said web member continuously descends, without opening or separation, from the upper edge thereof to said intersection.
 8. The intrauterine device of claim 4 wherein said resilient member comprises stainless steel wire.
 9. The intrauterine device of claim 4 wherein said plastic or rubber material comprises medical grade silicone rubber.
 10. An intrauterine device comprising a resilient Y-shaped member, said resilient member having two arms gradually and continuously diverging upwardly and outwardly from the intersection thereof adjacent the base portion of said resilient member; each of said arms being, at the uppermost portion thereof, curved outwardly, downwardly and inwardly to form a bent-back portion in the form of a partial loop terminating short of contacting the body of the adjacent arm; said resilient member being totally encased in a plastic or rubber materIal; the encasement about each of said partial loops being in the form of a bead having two flat surfaces parallel to each other and parallel to a plane passing through said resilient member, and a curved outside face along said bent-back portion, said curved outside face adapted to contact the adjacent sidewall of the uterus when said intrauterine device is in position with the uterus, said contact being maintained during use in the uterus by the resilient nature of said resilient member; said arms being sufficiently resilient so said arms can be urged together during positioning of said intrauterine device in an inserter for insertion of said intrauterine device into the uterus whereby adjacent flat surfaces on said beads will abut one another, and said curved outside faces will define a smooth leading-edge portion adapted to facilitate insertion of said intrauterine device into the uterus; a unitary web member extending between said encased arms, all of said web member being between said intersection and a line passing through said beads, said web member continuously descending, without opening or separation, from the upper edge thereof to said intersection; and a flexible tail portion extending downwardly from said intersection and adapted to extend outwardly from the uterus through the cervix when said intrauterine device is in position within the uterus.
 11. The intrauterine device of claim 10 wherein said resilient member comprises medical grade stainless steel wire and said medical grade plastic or rubber material comprises silicone rubber. 